Today, 25 May 2017, two new Regulations come into force in the European Union: the Medical Device Regulation (MDR) which replaces two EU Directives on general medical devices and active implantable medical devices; and the In Vitro Diagnostic Medical Devices Regulation (IVD MDR) which replaces the EU Directive on IVD medical devices. Now begins a transition period of three years under the MDR and five years under the IVD MDR.
The Regulations provide that CE certificates issued by notified bodies under the current Directives can remain valid during the transition period. A set of exemptions from clinical investigation requirements have also been introduced for products placed on the market under the Directives, provided that their clinical evaluation is based on sufficient clinical data and that they are in compliance with relevant common specifications.
The European Commission has stated (see here and here) that the new Regulations bring a number of improvements:
- Improve the quality, safety and reliability of medical devices: Tighter controls have been imposed on high-risk medical devices, including Class III implantable devices, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Rules on clinical evaluations and clinical investigations (and, for IVD medical devices, performance studies) have generally been strengthened. Controls have also been tightened on notified bodies. The new rules will cover certain previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision) as well. In addition, a new system for risk classification in line with international guidelines will apply to IVD medical devices.
- Strengthen transparency of information for consumers: The new Regulations will make sure that vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (Eudamed). Eudamed will contain a living picture of the lifecycle of all products being available in the EU. A large part of the information will be made publicly available, including a newly introduced summary of safety and performance for all Class III and implantable devices.
- Strengthen European governance of the new regulatory system: Once devices are available for use on the market, manufacturers will be obliged to collect data about their performance and Member States will coordinate more closely in the field of market surveillance. The Regulations also strengthen governance by introducing a new Medical Device Coordination Group (MDCG), composed of Member States experts and chaired by the European Commission and by introducing a mandatory coordinated assessment of multinational clinical investigations.
MedTech Europe has welcomed the new Regulations stating that the MDR brings more detailed clinical evaluation requirements, a new scrutiny process and an increased Commission and Authority control and monitoring of a strengthen notified body system; and the IVD MDR represents a fundamental legislative change with new or major shifts in areas such as the classification system, performance evaluation and clinical evidence, and conformity assessment of IVDs.
